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Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a randomized controlled trial.
Am J Kidney Dis. 2012 Jan; 59(1):58-66.AJ

Abstract

BACKGROUND

The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear.

STUDY DESIGN

Randomized controlled trial.

SETTING & PARTICIPANTS

80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center.

INTERVENTION

Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 μg/d, for 16 weeks.

OUTCOMES

The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30% from baseline. All analyses were intention to treat.

RESULTS

Baseline characteristics in the 2 groups were similar. 21 patients (53%) on paricalcitol and 7 patients (18%) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95% CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95% CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups.

LIMITATIONS

Lack of blinding and use of surrogate end points.

CONCLUSIONS

Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT.

Authors+Show Affiliations

Division of Nephrology, Salem Veterans Affairs Medical Center, Salem, VA 24153, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21885174

Citation

Kovesdy, Csaba P., et al. "Paricalcitol Versus Ergocalciferol for Secondary Hyperparathyroidism in CKD Stages 3 and 4: a Randomized Controlled Trial." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 59, no. 1, 2012, pp. 58-66.
Kovesdy CP, Lu JL, Malakauskas SM, et al. Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a randomized controlled trial. Am J Kidney Dis. 2012;59(1):58-66.
Kovesdy, C. P., Lu, J. L., Malakauskas, S. M., Andress, D. L., Kalantar-Zadeh, K., & Ahmadzadeh, S. (2012). Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a randomized controlled trial. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 59(1), 58-66. https://doi.org/10.1053/j.ajkd.2011.06.027
Kovesdy CP, et al. Paricalcitol Versus Ergocalciferol for Secondary Hyperparathyroidism in CKD Stages 3 and 4: a Randomized Controlled Trial. Am J Kidney Dis. 2012;59(1):58-66. PubMed PMID: 21885174.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a randomized controlled trial. AU - Kovesdy,Csaba P, AU - Lu,Jun L, AU - Malakauskas,Sandra M, AU - Andress,Dennis L, AU - Kalantar-Zadeh,Kamyar, AU - Ahmadzadeh,Shahram, Y1 - 2011/08/31/ PY - 2011/03/29/received PY - 2011/06/28/accepted PY - 2011/9/3/entrez PY - 2011/9/3/pubmed PY - 2012/2/14/medline SP - 58 EP - 66 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 59 IS - 1 N2 - BACKGROUND: The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear. STUDY DESIGN: Randomized controlled trial. SETTING & PARTICIPANTS: 80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center. INTERVENTION: Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 μg/d, for 16 weeks. OUTCOMES: The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30% from baseline. All analyses were intention to treat. RESULTS: Baseline characteristics in the 2 groups were similar. 21 patients (53%) on paricalcitol and 7 patients (18%) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95% CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95% CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups. LIMITATIONS: Lack of blinding and use of surrogate end points. CONCLUSIONS: Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/21885174/Paricalcitol_versus_ergocalciferol_for_secondary_hyperparathyroidism_in_CKD_stages_3_and_4:_a_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(11)01139-5 DB - PRIME DP - Unbound Medicine ER -